Tool and method for implanting an annuloplasty prosthesis

ABSTRACT

A simplified and more easily employed tool for holding an implantable annuloplasty prosthesis during passage of sutures through the prosthesis and for conveniently and efficiently releasing the prosthesis from the tool. Separation of the implantable prosthesis and the tool may be conveniently accomplished without requiring the use of a sharp instrument. Attachment between the prosthesis and its surgical carrying tool can be accomplished in a suture-less fashion. The tool includes a suture management device in some embodiments for selectively receiving and maintaining sutures otherwise securing the prosthesis to tissue.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit under §119(e)(1), and incorporatesherein by reference an entirety of, U.S. Provisional Application No.60/722,525, filed Sep. 30, 2005 and entitled “Tool and Method forImplanting an Annuloplasty Prosthesis.”

BACKGROUND OF THE INVENTION

The present invention relates generally to surgical tools and methods ofimplantation. More particularly, it relates to surgical tools andmethods used in conjunction with heart repair procedures, includingtools for holding prostheses such as annuloplasty rings or bands.

Improvements in cardiopulmonary bypass and myocardial protection andstandardization of surgical techniques have lead to increasing interestin valve reconstruction procedures. See, for example, Ormiston J A, ShahP M, Tei C, et al., Size and Motion in the Mitral Valve Annulus in Man,Circulation 1981; 64:113; Dagum P, Green G R, Glasson J R, et al.,Potential Mechanism of Left Ventricular Outflow Tract Obstruction AfterMitral Ring Annuloplasty, J Thorac Cardiovasc Surg. 1999;117:472-80;David T E, Armstrong S, Sun Z, Left Ventricular Function After MitralValve Surgery, J Heart Dis 1995; 4:S175-80; and Duran C, Perspectivesfor Acquired Valvular Disease, Advanced Cardiac Surgery, Vol. 4, 1993.

As highlighted by the above, annuloplasty bands and rings have beenrecognized as being highly useful in a variety of surgical procedures,including mitral and tricuspid valve repair. In general terms, currenttechniques for implanting an annuloplasty ring or band includes theannuloplasty device initially being secured to a holder that facilitatessimplified manipulation of the annuloplasty device during theimplantation procedure. Because heart valve annulus size varies frompatient to patient, a plurality of sizers are typically used to identifythe appropriate size for the holder. Once the appropriate size isidentified, the correspondingly-sized holder is selected from aninventory of different sized holders. This process can be time consumingand requires large inventories of both sizers and holders.

Once the appropriately-sized holder/annuloplasty device has beenselected, sutures are then placed around all or portions of the valveannulus at spaced intervals. To this end, a typical suture arrangemententails looping a suture through the annular tissue that opposing endsor segments of the suture define a suture pair. With this technique, aplurality of sutures are employed, thus defining a plurality of suturepairs (i.e., once looped through the annular tissue, opposing ends orsegments of the suture extend from the annular tissue to define a“suture pair”). Spacing along the annular tissue between the segmentsassociated with a particular suture pair can vary depending upon whetherit is desired to plicate (or reduce) a region of the annulus to whichthe suture pair is applied (e.g., a suture pair will be spacedapproximately 4 mm in width where no plication is necessary, andapproximately 5-6 mm in width where plication is desired). Regardless,the sutures are then brought through the annuloplasty device (with anequal spacing between suture pair segments relative to the annuloplastydevice determined by whether or not plication is desired).

The process of passing the sutures through the annuloplasty deviceoccurs while the prosthesis is maintained by the holder/tool at a pointspaced from the valve annulus. For virtually all procedures in whichmultiple sutures, and thus multiple suture segment pairs, are required,once threaded through the annuloplasty device, the suture segments mustbe discretely positioned and held away from the surgical site so as tonot interfere with threading of other suture segments through theannuloplasty device, to avoid entanglement with other suture segments,maintain an organizational flow to the threading of sutures, etc. Theconventional approach to this suture management requirement entailssecuring the sutures within one or more separate suture holding deviceslocated away from the surgical field. Unfortunately, the sutures canbecome entangled and it is sometimes difficult to identify correspondingsegments of a suture pair.

Once all necessary suture segments have been placed through theannuloplasty device, the annuloplasty device is then removed from theholder. Conventional annuloplasty holders entail the use of one or moresutures that secure the annuloplasty device to the holder. With thisapproach, to release the annuloplasty device, a sharp instrument such asa knife or scalpel is used to cut the suture(s) that otherwise connectsthe annuloplasty device to the holder frame. While accepted, this hasthe disadvantage of requiring the use of a sharp instrument in closeproximity to sensitive anatomical structures and in even closerproximity to the prosthetic repair device which typically has a fabriccover that can otherwise be relatively easily severed. Further, knownannuloplasty device holder designs give rise to the potential ofimproperly separating the device-retaining suture(s) in more than onelocation. This may increase the chance that a stray piece of the cutsuture(s) may remain in the patient's body.

Various systems for use in heart repair procedures are disclosed in U.S.Pat. Nos. 5,011,481; 5,290,300; 5,496,336; 5,638,402; 5,522,884;6,174,332; 6,283,993; 6,558,416; and 6,719,786. Prosthesis and surgicalmethods for implanting prostheses for addressing heart disorders aredescribed in Okada Y, Shomura T, Yamura Y I, et al., Comparison of theCarpentier and Duran Prosthetic Rings Used in Mitral Reconstruction, AnnThorac Surg 1995; 59:658-63; Duran C M G; Ubago J L M; Clinical andHemodynamic Performance of a Totally Flexible Prosthetic Ring forAtrio-Ventricular Valve Reconstruction, Ann Thorac Surg 1976; 22:458-63;and Van Rijk-zwikker G L, Mast F, Shepperheyn J J, et al., Comparison toFlexible Rings for Annuloplasty of the Mitral Valve, Circulation, 1990;82 (Suppl. IV):IV 58-64.

Annuloplasty devices continue to be highly important tools for repairingheart valves. Unfortunately, the instruments used in connection withimplantation of the annuloplasty prosthesis are cumbersome. Therefore, aneed exists for an implantation tool and related surgical method forimplanting an annuloplasty device.

SUMMARY

In one aspect, the present invention generally is directed toward asimplified and more easily employed tool for holding an implantableannuloplasty prosthesis during passage of sutures through the prosthesisand for conveniently and efficiently releasing the prosthesis from thetool. Separation of the implantable prosthesis and the tool may beconveniently accomplished without requiring the use of a sharpinstrument. Attachment between the prosthesis and the surgical carryingtool can be accomplished in a suture-less fashion.

In one embodiment, a tool for use in implanting an annuloplastyprosthesis to repair a heart valve is provided and includes an elongateproximal portion and a distal portion. The proximal portion forms ahandle. The distal portion includes first and second jaws, at least oneof which is mounted for relative movement between an open state and aclosed state. In the open state, an end section of the first jaw isspaced apart from a corresponding end section of the second jaw. In theclosed state, a spacing between the corresponding end sections of thejaws is less than the spacing in the open state. In one preferredembodiment, the tool further includes an actuator mechanism having anexteriorly accessible actuator providing a single actuation point for auser to effectuate transition of the jaws from the closed state to theopen state in releasing an annuloplasty prosthesis from the tool. Inanother preferred embodiment, the tool further includes a suturemanagement device.

In another aspect, the present invention generally is directed toward amethod of repairing a heart valve by implanting an annuloplastyprosthesis. The method is characterized by the absence of a need toemploy a sharp instrument to effectuate release of the annuloplastydevice from a tool otherwise maintaining the annuloplasty device duringa portion of the implantation procedure.

In one embodiment, the method includes providing an implantableannuloplasty prosthesis and a tool. The tool has first and second jaws,at least one of which is movable relative to the other between an openstate and a closed state. In the open state, an end section of the firstjaw is spaced apart from a corresponding end section of the second jaw.In the closed state, a spacing between the corresponding end sections isless than the spacing in the open state. With this in mind, the jaws aretransitioned to the open state, and the implantable prosthesis ispositioned against the end section of at least one of the jaws. Theimplantable prosthesis is secured to the tool by transitioning the jawsto the closed state. At least one suture is attached to heart tissue andthen passed through the implantable prosthesis while the implantableprosthesis is otherwise secured to the tool. The jaws are transitionedto the open state and the implantable prosthesis is removed from thetool. Once removed, the implantable prosthesis is moved to an implantlocation and at least one suture is secured so that it resists movementof the implantable prosthesis relative to the heart tissue. In onepreferred embodiment, segments of at least one suture are selectivelymaintained by a suture management device provided by the tool.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a perspective view of one embodiment of a tool for use inimplanting an annuloplasty prosthesis according to principles of thepresent invention;

FIG. 1B is an exploded view of the tool of FIG. 1A;

FIG. 2A is a top plan view of a first jaw portion of the tool of FIG.1A;

FIG. 2B is a side view of the first jaw of FIG. 2A;

FIG. 2C is a bottom plan view of the first jaw of FIG. 2A;

FIG. 3A is a bottom plan view of a second jaw portion of the tool ofFIG. 1A;

FIG. 3B is a cross-sectional view of the second jaw of FIG. 3A;

FIG. 4A is a bottom plan view of a distal portion of the tool of FIG. 1Aillustrating assembly of an actuator mechanism;

FIG. 4B is a top plan view of the distal portion of FIG. 4A;

FIG. 4C is a cross-sectional view of the tool of FIG. 4B taken along thelines 4C-4C;

FIG. 5 is a perspective view of a portion of the tool of FIG. 1A showingthe jaws in a closed state;

FIG. 6 is a side view of the portion of the tool of FIG. 1A showing thejaws in an open state;

FIG. 7A is an enlarged, top view of a portion of the tool of FIG. 1Aillustrating a suture management device in accordance with principles ofthe present invention;

FIG. 7B is an enlarged, simplified end view of the suture managementdevice of FIG. 7A;

FIG. 8A is a perspective view of the portion of the tool of FIG. 1A withthe jaws in an open state in combination with an implantableannuloplasty prosthesis;

FIG. 8B is a side view of the combination of FIG. 8A;

FIG. 9 is an enlarged perspective view of the combinationtool/annuloplasty prosthesis, with the jaws in a closed state; and

FIGS. 10A-15 illustrate some embodiments of a method for implanting anannuloplasty prosthesis according to principles of the presentinvention.

DETAILED DESCRIPTION

Tool 20

One embodiment of a tool 20 for use in implanting an annuloplastyprosthesis (not shown) such as an annuloplasty band or ring is shown inFIGS. 1A and 1B. The tool 20 includes an elongate proximal portion 22, adistal portion 24, an actuator mechanism 26 (referenced generally), anda suture management device 28. Details on the various components areprovided below. In general terms, however, the proximal portion 22defines a handle 30 that is sized and shaped to be manually grasped by asingle hand of a user. The distal portion 24 includes first and secondjaws 32, 34 mounted for relative movement between i) an open state inwhich the jaws 32, 34 are spaced apart to receive or release animplantable annuloplasty prosthetic, and ii) a closed state (shown inFIG. 1A) in which the first and second jaws 32, 34 are spaced closertogether than in the open state. The actuator mechanism 26 facilitatesmovement of the jaws 32, 34 between the open and closed states. Withthis construction, the tool 20 facilitates annuloplasty deviceimplantation without requiring a cutting instrument to effectuaterelease of the annuloplasty device from the tool 20. Finally, the suturemanagement device 28 provides a convenient system for selectivelymaintaining one or more sutures (not shown) on the tool 20 itself.

The proximal portion 22 defines the handle 30 to generally have anintermediate segment 38 extending between a proximal end 40 and a distalneck 42. In one embodiment, and as described in greater detail below,the proximal end 40 forms a portion of the suture management device 28.Regardless, the neck 42 extends from the intermediate segment 38 todefine a transition of the proximal portion 22 to the distal portion 24.In one embodiment, the intermediate segment 38 defines a curvature 44adjacent the neck 42, with the curvature 44 providing an ergonomicallyconvenient location for a user's thumb (not shown) during normalhandling of the tool 20. In addition, an upper surface 46 of the neck 42extends downwardly (relative to a central axis of the handle 30) fromthe intermediate segment 38 in a curved fashion. With thisconfiguration, a user's thumb readily engages a component of theactuator mechanism 26 as the handle 30 is otherwise grasped in theuser's palm, as described in greater detail below. To this end, the neck42 defines a ledge 48 relative to the intermediate segment 38. The ledge48 is sized and shaped to provide a perceptible stop surface for theuser's thumb to impede accidental user activation of the actuatormechanism 26 during normal handling of the tool 20. Alternatively, thehandle 30, including the neck 42, can assume a wide variety of othershapes, sizes, or configurations.

First Jaw 32

The distal portion 24 extends from the neck 42 and, as previouslydescribed, includes the first jaw 32 and the second jaw 34. Withadditional reference to FIGS. 2A and 2B, in one embodiment, the firstjaw 32 includes an upper surface 60 and a lower surface 62, and definesan end section 64 and a base section 66. In one embodiment, the firstjaw 32 is homogenously and integrally formed with the neck 42 such thatthe upper surfaces 46, 60 are continuous. Alternatively, the first jaw32 can be formed separately.

The end section 64 terminates at a leading end 68. The leading end 68defines an elongated surface corresponding with a portion of the secondjaw 34 for assisting in retaining an annuloplasty prosthesis (not shown)relative to the second jaw 34 as described below. In this regard, theleading end 68 is substantially linear and elongated, defining a planethat is substantially perpendicular to a longitudinal axis of the handle30 (best shown in FIGS. 1A and 1B). Stated otherwise, a width defined bythe leading end 68 (i.e., dimension transverse to an axis of the handle30) is greater than a width of the neck 42.

In one embodiment, and as best shown in FIG. 2A, the upper surface 60 atthe end section 64 includes indicia 70 (referenced generally)representing incremental units of measurement (e.g., millimeters)extending from a first side 72 of the end section 64 to a second side74. For example, a first mark 75 a adjacent the first side 72 isindicative of a “zero” point, with additional markings representingmeasured distances from the zero mark 75 a (e.g., a second mark 75 b inFIG. 2A is 50 mm from the zero mark 75 a). As described in greaterdetail below, the indicia 70 facilitates accurate placement of sutures(not shown) through an annuloplasty prosthetic otherwise secured to thetool 20, as well as an indication of a length of the prosthetic. Inaddition, or as an alternative to the “dash” marks, the indicia 70 caninclude other nomenclature such as numbers, words, (e.g., that explainuse of the tool 20), symbols, etc. In alternative embodiments, theindicia 70 is omitted.

Finally, in one embodiment, the end section 64 includes a plurality ofprotrusions 76 extending distally from the leading end 68. As best shownin FIGS. 1B and 2B, each of the protrusions 76 maintains a holdingmember 78. The holding members 78 project downwardly relative to thelower surface 62 (as best shown in FIG. 2B) and are adapted to penetrateinto an annuloplasty prosthesis (not shown) otherwise maintained by thesecond jaw 34, to resist separation between the annuloplasty device andthe tool 20 as described in greater detail below. The protrusions 76,and thus the holding members 78, are uniformly spaced along a width ofthe end section 64 in one embodiment; alternatively, the holding members78 can be non-uniformly spaced. In one embodiment, the holding members78 are uniformly sized pins, but can assume a variety of otheracceptable forms such as ribs, detents, barbs, pegs, needles, etc., thatdo not necessarily have to “enter” the annuloplasty prosthesis in orderto retain the prosthesis relative to the tool 20. Regardless, in oneembodiment and as best shown in FIG. 2B, the end section 64 defines astep 80 (relative to the base section 66) along the lower surface 62 toaccommodate a length of the holding members 78 as well as acorresponding feature of the second jaw 34 as described below.

The base section 66 extends from the neck 42 to the end section 64 and,in one embodiment, forms an opening 86 and includes a post 88 andmounting elements 90. The opening 86 extends through a thickness of thebase section 66 adjacent the opening 86 and is sized to receive aportion of the actuator mechanism 26 (FIG. 1B), as described in greaterdetail below. Along these same lines, the upper surface 60 along thebase section 66 is preferably flat to facilitate operation of theactuator mechanism 26. Similarly, the post 88 forms a component of theactuator mechanism 26, and is described in greater detail below. Ingeneral terms, however, the post 88 extends upwardly from the uppersurface 60 adjacent the opening 86 and forms a channel 92.

With reference to FIGS. 2B and 2C, the mounting elements 90 are formedon or extend from the lower surface 62, and are adapted to facilitatemounting of the first and second jaws 32, 34 to one another in a mannerthat allows hinged or pivoting movement of the jaws 32, 34. In oneembodiment, the mounting elements 90 are pairs of opposing clamp fingers92. While four of the clamp fingers 92 are shown (FIG. 2C), any othernumber, either greater or lesser, is also acceptable. Alternatively, awide variety of pivotable mounting configurations can be employed.

Second Jaw 34

Returning to FIG. 1B, and with additional reference to FIGS. 3A and 3B,the second jaw 34 includes an inner surface 100 (FIG. 3B) and an outersurface 102, and defines an end section 104 and a base section 106. Theend section 104 defines a channel 108 (best shown in FIGS. 1B and 3B)sized to receive an annuloplasty prosthesis (not shown). In this regard,the channel 108 is defined, in one embodiment, by a plurality of fingers110 and a plurality of projections 112. Each of the fingers 110 includesa base 114 and a head 116. As best shown in FIG. 3B, the base 114extends upwardly from the inner surface 100, with the collective bases114 combining to define a lateral face 118 of the channel 108. The head116 extends distally from the base 114 opposite the inner surface 100,with the collective heads 116 combining to define a first longitudinalface 120 of the channel 108. The plurality of fingers 110 areintermittently spaced so as to accommodate passage of the holdingmembers 78 (FIG. 1B) associated with the first jaw 32.

The projections 112 extend substantially parallel to the firstlongitudinal face 120 provided by the heads 116, and combine to define asecond longitudinal face 122 of the channel 108. In one embodiment, theprojections 112 are intermittently spaced. Alternatively, however, acontinuous structure can be defined. In one embodiment, each of theprojections 112 forms a hole 124 sized to receive a corresponding one ofthe holding members 78. Alternatively, depending upon the exactconfiguration of the holding member 78, the projections 112 can assume avariety of other forms. Regardless, the lateral face 118, the firstlongitudinal face 120, and the second longitudinal face 122 each serveas a receiving surface against which an annuloplasty prosthesis (notshown) can be placed. Thus, the channel 108 serves as a holding zone forthe annuloplasty prosthesis as described below. As shown in FIG. 1B, thechannel 108 is substantially linear, extending in a plane substantiallyperpendicular to an axis of the handle 30.

In one embodiment and with specific reference to FIG. 1B, the basesection 106 includes a post 130 extending from a trailing edge 132thereof. The post 130 forms a portion of the actuator mechanism 26. Ingeneral terms, however, the post 130 extends in a generallyperpendicular fashion relative to the end section 104 and forms a slot134. In addition, the post 130 includes opposed tabs 136 extending in atransverse fashion. The slot 134 and the tabs 136 facilitate assembly ofthe actuator mechanism 26, with the post 130 adapted to translate aforce onto the end section 104. In addition, and as best shown in FIG.3A, the base section 106 of the second jaw 34 forms engagement segments138 adapted to facilitate mounting of the second jaw 34 to the first jaw32 (FIG. 1B). For example, in one embodiment, the engagement segments138 are defined by one or more apertures 140 formed adjacent thetrailing edge 132. The apertures 140 are sized to receive a respectiveone of the clamp fingers 92 (FIG. 2B), with the trailing edge 132 ateach of the engagement segments 138 serving as a pivot point formovement of the second jaw 34 relative to the first jaw 32.

Actuator Mechanism 26

The actuator mechanism 26 includes, in one embodiment, an actuator 150,a biasing device 152, and a capturing assembly 154 (referenced generallyin FIG. 1B), that, in one embodiment, includes the post 88 associatedwith the first jaw 32 and the post 130 associated with the second jaw34. In general terms, the actuator 150 provides a force-receivingsurface for a user to effectuate movement of the jaws 32, 34, with thebiasing device 152 forcing the actuator mechanism 26 to a naturallyclosed state.

The actuator 150 can assume a variety of forms, but in one embodiment isa button defining a pressing surface 156 (referenced generally in FIG.1B) and a guide surface 158. The pressing surface 156 is preferablycontoured to readily receive a single digit (i.e., thumb or finger) of auser. The guide surface 158 is preferably smooth for reasons describedbelow. In one embodiment, the actuator 150 is formed as a shell,defining an interior region within which various other components of theactuator mechanism 26 can reside. Further, the actuator 150 isconfigured for attachment to the post 130 provided by the second jaw 34via opposing notches 160 (one of which is shown in FIG. 1B) thatotherwise engage a respective one of the tabs 136. Alternatively, avariety of other configurations can be employed to accomplish assemblyof the actuator 150 to the post 130. Preferably, however, the actuator150 can slightly pivot relative to the post 130 (e.g., in oneembodiment, the notches 160 are sized to allow pivoting of the actuator150 relative to the tabs 136).

The biasing device 152 is, in one embodiment, a compression springadapted to bias the posts 88, 130 away from one another, as describedbelow. With this configuration, then, the spring 152 biases the endsections 64, 104 of the jaws 32, 34 to the closed state of FIG. 1A.Alternatively, the biasing device 152 can assume a variety of otherforms. Even further, in other embodiments, the biasing device 152 iseliminated. More particularly, the actuator mechanism 26 can beconfigured to include or define structures associated with the first andsecond jaws 32, 34 that serve to selectively lock the jaws 32, 34 in theclosed state. As described below, an annuloplasty prosthesis (not shown)is secured by the jaws 32, 34 in the closed state, such that byfacilitating “locking” of the jaws 32, 34 in the closed state,unintended dislodgement of the prosthesis from the jaws 32, 34 isprevented. For example, a detent assembly can be provided (e.g., thepost 130 forms a protrusion sized to be captured within a correspondingaperture formed along the opening 86 when the jaws 32, 34 are in theclosed state) that effectively serves the same function as the biasingdevice 152.

Jaw/Actuator Mechanism Assembly

Assembly of the actuator mechanism 26, the first jaw 32, and the secondjaw 34 is best described with reference to FIGS. 4A-4C. The second jaw34 is pivotally mounted to the first jaw 32 by inserting the engagementsegments 138 of the second jaw 34 within the clamping fingers 92 of thefirst jaw 32 as best shown in FIG. 4A. In particular, each of therespective pairs of clamping fingers 92 capture the correspondingengagement segment 138 via the trailing edge 132 and the apertures 140.With this assembly, then, the second jaw 34 can pivot relative to thefirst jaw 32 via rotation of the end segments 138 within the mountingelements 90, respectively. In addition, and as best shown in FIG. 4B(that otherwise illustrates the tool 20 with the actuator 150 removed),the post 130 of the second jaw 34 protrudes through the opening 86 inthe first jaw 32. The biasing device 152 is captured at opposing endsthereof within the posts 88, 130. More particularly, the biasing device152 nests within the channel 92 of the post 88 and the slot 134 of thepost 130. Finally, as shown in FIG. 4C, the actuator 150 is assembled tothe post 130 of the second jaw 34, for example by placing the actuator150 over the post 130 such that the tabs 136 (FIG. 1B) are receivedwithin respective ones of the notches 160 (FIG. 1B).

The final assembly is shown in FIG. 4C. Once assembled, the biasingdevice 152 forces the jaws 32, 34 to a closed state as shown (i.e.,forces or biases the post 130 of the second jaw 34 away from the post 88of the first jaw 32). In particular, a force imparted on the post 130 bythe biasing device 152 is translated along the second jaw 34 to theconnection point between the jaws 32, 34 (i.e., interface between themounting elements 90/end segments 138 as shown in FIG. 4A), thus forcingthe end sections 64, 104 toward one another, with the lower surface 62of the first jaw 32 abutting the inner surface 100 of the second jaw 34.Alternatively, the actuator mechanism 26, the first jaw 32, and/or thesecond jaw 34 can assume a variety of other forms capable ofeffectuating a biased, closed state and selective movement to an openstate.

A closed state of the jaws 32, 34 is better illustrated in FIG. 5. Inparticular, the end sections 64, 104 are in close proximity to oneanother, with the holding members 78 received within respective ones ofthe holes 124 (shown generally) provided by the projections 112 of thesecond jaw 34. A spacing and arrangement of the holding members 78corresponds with that of the fingers 110, such that respective ones ofthe holding members 78 are positioned between adjacent fingers 110 andvice-versa.

The jaws 32, 34 can be transitioned to an open state via the actuatormechanism 26 and in particular via a force applied to the actuator 150.With reference to FIG. 4C, a user-applied force is imparted upon thepressing surface 156 of the actuator 150 and is thus translated to thepost 130 of the second jaw 34. When the user-applied force is sufficientto overcome a bias of the biasing device 152, the post 130 of the secondjaw 34 moves toward the post 88 of the first jaw 32, with the actuator150 sliding relative to the first jaw 32 via a smooth interface providedbetween the guide surface 158 of the actuator 150 and the upper surface60 of the first jaw 32. As best shown in FIG. 6, as the post 130 moves,the second jaw 34 pivots relative to the first jaw 32 at the interfacebetween the mounting members 90 and the engagement segments 138 (one ofwhich is shown in FIG. 6), such that the end section 104 of the secondjaw 34 moves laterally away from the end section 64 of the first jaw 32,resulting in an open state of the jaws 32, 34 in which a spacing betweenthe end sections 64, 104 is generated. In the open state, and as shownin FIG. 6, the holding members 78 are spaced from the end section 104 ofthe second jaw 34, such that the channel 108 is fully open and availableto receive an annuloplasty prosthesis (not shown) as described below.Upon removing the user-applied force to the actuator 150 and withreference to FIG. 4C, the biasing device 152 forces the post 130 of thesecond jaw 34 away from the post 88 of the first jaw 32, thustransitioning the jaws 32, 34 back to a closed state.

Suture Management Device 28

Returning to FIG. 1B, the suture management device 28 includes, in oneembodiment, a flexible, resilient member 170 that is assembled to theproximal portion 22. For example, with reference to FIG. 7A, theproximal portion 22 forms opposing legs 172 a, 172 b that combine todefine a gap 174. The flexible, resilient member 170 is configured tonest within the gap 174 and defines opposing, first and second edges 176a, 176 b. To this end, in an undeformed state, the flexible member 170encompasses a width of the gap 174 (it being understood that forpurposes of clarity, the flexible member 170 is shown in FIG. 7 ashaving a width slightly less than that of the gap 174). Thus, in anundeformed state, the first edge 176 a of the flexible member 170naturally bears against the leg 172 a, whereas the second, opposing edge176 b naturally bears against the leg 172 b. However, due to theinherent flexible, resilient nature of the flexible member 170, forexample by forming the flexible member 170 out of silicone or similarmaterial, the edges 176 a, 176 b are readily deflected away from thecorresponding leg 172 a, 172 b to form first and second slots 178 a, 178b, respectively (it again being understood that in the illustration ofFIG. 7A, the slots 178 a, 178 b are greatly exaggerated in size forpurposes of clarity; due to the resilient nature of the flexible member170, the slots 178 a, 178 b are not visually perceptible in the natural,undeformed state of the flexible member 170 in accordance with oneembodiment). The slots 178 a, 178 b each provide a receiving zone forselectively maintaining a thin body, such as a suture(s) as described ingreater detail below. Each of the slots 178 a, 178 b are sized andshaped to be capable of holding about ten to twenty 2-0 suturesotherwise used to attach an annuloplasty device to a heart valveannulus.

To facilitate suture insertion within the slots 178 a, 178 b, a topsurface 180 and a proximal end 182 of each of the legs 172 a, 172 b are,in one embodiment, formed with a chamfer that guides a suture(s) intothe corresponding slot 178 a or 178 b. This chamfered configuration ofthe top surface 180 is best shown in FIG. 7B, otherwise illustrating, insimplified form, an end view of the tool 20 (with other components, suchas jaws 32, 34 (FIG. 1A) omitted). In another embodiment, and withcontinued reference to FIGS. 7A and 7B, a proximal edge 183 (FIG. 7A)and an upper surface 184 (FIG. 7B) of the flexible member 170 adjacentthe edges 176 a, 176 b is similarly chamfered. Regardless, the flexiblemember 170 is adapted to frictionally retain suture(s) against thecorresponding leg 172 a, 172 b, and readily reverts to a configurationin which the flexible member 170 encompasses an entire width of the gap174 upon removal of the suture(s).

Alternatively, the suture management device 28 can assume a variety ofother forms. For example, the flexible member 170 can be formed of aharder material such as hardened plastic. Further, the suture managementdevice 28 can be configured to provide a single-receiving slot or amultiplicity (three or more) of suture-receiving slots. In otherembodiments, the suture management device 28 includes one or moreclamping mechanisms (e.g., a spring-loaded clamp formed by, or attachedto, the proximal end 40 of the handle 30). Along these same lines, inother alternative embodiments, the suture management device 28, or anyof the alternative suture management device configurations describedabove, can be employed with a tool (for use in implanting anannuloplasty prosthesis) that does not include the jaws 32, 34/actuatormechanism 26 described above, but instead incorporates an entirelydifferent prosthesis retaining configuration, such as that associatedwith conventional annuloplasty device holders (e.g., a body forming aslot within which the prosthesis is received in combination with one ormore sutures that secure the prosthesis within the slot).

Methods of Use/Implantation

During use, the tool 20 is capable of holding and releasing anannuloplasty prosthesis in a highly convenient manner to facilitate animplantation procedure. For example, FIGS. 8A and 8B illustrate thedistal portion 24 of the tool 20 in combination with an annuloplastyprosthesis 200. The annuloplasty prosthesis 200 is shown generically inFIGS. 8A and 8B, and can assume a variety of forms. For example, in oneembodiment, the prosthesis 200 is a flexible annuloplasty band, butalternatively can be an annuloplasty ring. Alternatively, the prosthesis200 can be any elongated structure, such as a rod, bar, or cord. Theprosthesis 200 can be flexible, partially flexible, resilient, orpartially resilient. The cross-sectional shape of the prosthesis 200 canbe of any suitable shape such as, but not limited to, circular,polygonal, square, rectangular, elliptical, or combinations thereof. Theprosthesis 200 can comprise a unitary or composite structure.Alternatively, the prosthesis 200 can be constructed of segments orelements with different properties such as stiffness, rigidity, and/orradiopacity. Optionally, the prosthesis 200 may include a drug ortherapeutic agent that tends to be slowly released or eluded from theprosthesis 200.

Regardless of exact configuration, the annuloplasty prosthesis 200 isinitially mounted to the tool 20 by first transitioning the jaws 32, 34to an open state shown in FIG. 8A. In particular, while the handle 30(FIG. 1A) is grasped by the user's single hand (not shown), the thumb orfinger of that hand slides along the upper surface 46 of the neck 42 andeasily reaches the actuator button 150, contacting the pressing surface156 (referenced generally in FIG. 8A). A pushing force is then applied(e.g., by the single digit of the user's hand) to the actuator button150, causing the actuator mechanism 26 (FIG. 4C) to transition the jaws32, 34 from a closed state (FIG. 1A) to the open state of FIG. 8A aspreviously described. With the jaws 32, 34 maintained in the open state(via continuous user-imparted force applied to the actuator button 150),the annuloplasty prosthesis 200 is inserted within the channel 108(reference generally in FIG. 8A, but shown more clearly in FIG. 6) ofthe second jaw 34. To this end, insertion of the annuloplasty prosthesis200 is characterized by the annuloplasty prosthesis 200 contacting thelateral face 118 defined by the fingers 110 and the second longitudinalface 122 provided by the projections 112 as best shown in FIG. 8B.Depending upon a thickness of the annuloplasty prosthesis 200, the firstlongitudinal face 120 defined by the fingers 110 may also be contacted.Regardless, the second longitudinal face 122 provides a convenientsurface for sliding the annuloplasty prosthesis 200 into contact withthe lateral face 118, with the lateral face 118 providing a stop surfacethat ensures a desired position of the annuloplasty prosthesis 200relative to the holding members 78 (one of which is shown in FIG. 8B).

Once inserted, the annuloplasty prosthesis 200 is secured to the tool 20by transitioning the jaws 32, 34 to a closed state as shown in FIG. 9.More particularly, the user-applied force on the actuator button 150 isremoved, with the actuator mechanism 26 (and in particular the biasingdevice 152 (FIG. 4C)) causing the end section 104 of the second jaw 34to transition or move toward the end section 64 of the first jaw 32. Inthe closed state, the holding members 78 pierce or penetrate into theannuloplasty prosthesis 200 (e.g., a cloth covering), thus securing theannuloplasty prosthesis 200 to the tool 20. The biasing device 152 (orother locking-type structure previously described) maintains the jaws30, 34 in a closed state to prevent dislodgement of the annuloplastyprosthesis 200 from the tool 20. Alternatively, depending upon aconfiguration of the annuloplasty prosthesis 200 and/or the holdingmembers 78, securement of the annuloplasty device 200 to the tool 20 cantake other forms that do not necessarily entail piercing of theannuloplasty device 200. Preferably, however, separate tying device(s)(e.g., sutures) are not required. Regardless, the annuloplastyprosthesis 200 is retained by the tool 20 in a straight line or linearfashion. This allows a surgeon to more clearly identify desired suturespacing along the prosthesis 200 (described below) as opposed toconventional holders that maintain the prosthesis 200 in a curved shape.

The annuloplasty prosthesis 200 can subsequently be released from thetool 20 by transitioning the jaws 32, 34 to an open state (FIG. 8A) aspreviously described. In this regard, as the end section 104 of thesecond jaw 34 is transitioned or pivoted away from the end section 64 ofthe first jaw 32, temporary frictional engagement between the holdingmembers 78 and the annuloplasty prosthesis 200 (e.g., due to piercing ofannuloplasty prosthesis 200 by the holding member 20 in one embodiment),may cause the prosthesis 200 to “move” with the first jaw 32. With thisin mind, with transition to an open state, the annuloplasty prosthesis200 contacts or abuts the first longitudinal face 120 (FIG. 8B) of thefingers 110. Thus, the annuloplasty prosthesis 200 remains associatedwith the second jaw 34, thereby allowing the holding members 78 to fullydisengage from the annuloplasty prosthesis 200 as the jaws 32, 34transition to an open state. Once the holding members 78 have beendisengaged, the annuloplasty prosthesis 200 can then easily be removedfrom the channel 108, and thus the tool 20. Notably, the above-describedmounting and removal of the annuloplasty prosthesis 200 is accomplishedvia single push/point maneuver of the actuator button 150 by a singledigit (not shown) of the user's hand (not shown). Unlike previousannuloplasty device holders, the tool 20 of the present invention doesnot require tying of sutures or similar devices to secure theannuloplasty prosthesis 200 to the tool 20, nor does it require cuttingof sutures or any other use of a sharp instrument to effectuate removalof the annuloplasty prosthesis 200 from the tool 20.

With the above understanding of the tool 20/annuloplasty prosthesis 200relationship in mind, the tool 20 can be used to facilitate a wideverity of heart valve repair procedures, such as, for example, mitral ortricuspid annuloplasty in conjunction with an implantable annuloplastyband or ring.

Implantation of the annuloplasty prosthesis 200 begins (before or aftersecuring the prosthesis 200 to the tool 20) by placing sutures at thedesired target site. For example, FIG. 10A illustrates suture placementrelative to a mitral valve annulus 210 in accordance with oneembodiment. In particular, a first suture 212 is placed at the leftfibrous trigone 214 to define a suture pair (consisting of suturessegments 212 a, 212 b) approximately 4 mm in width. Working along aposterior 216 of the annulus 210 from the left fibrous trigone 214 to aright fibrous trigone 218 (in a direction indicated by an arrow in FIG.10A), adjacent interrupted sutures 220-234 are consecutively placedapproximately 1-2 mm from the previous suture, with each of the sutures220-234 forming suture pairs (e.g., the second suture 220 forms a suturepair consisting of segments 220 a, 220 b, etc.). Each suture/suture pair220-234 is spaced approximately 4 mm where no plication is necessary,and approximately 5-6 mm in width where plication is desired. The lastsuture pair 234 (approximately 4 mm in width) is placed at the rightfibrous trigone 218. With this one technique, approximately 8-10 suturesmay be placed in the mitral valve annulus 210. Alternatively, a varietyof other suturing techniques can be employed.

The above-described series-type suture placement can also be employedfor repair of a tricuspid valve annulus 240 as shown in FIG. 10B. Afirst suture 242 is initially placed at a medial fibrous trigone 244 todefine a suture pair (i.e., suture segments 242 a, 242 b). Working alongthe anterior and posterior annulus 240 from the medial fibrous trigone244 to a posterior septal commissure 246 (in a direction shown by anarrow in FIG. 10B), adjacent sutures 248-262 (and thus suture pairs) areconsecutively placed in an interrupted fashion approximately 1-2 mm fromthe previous suture pair. Each suture pair 242, 248-262 is spacedapproximately 4 mm in width where no plication is necessary, andapproximately 5-6 mm in width where plication is desired. The lastsuture pair 262 is located at the posterior septal commissure 246, andis approximately 4 mm in width. With this technique, approximately 8-12sutures can be placed in the valve annulus 240. Alternatively, a widevariety of other suturing techniques can be employed.

Regardless of the valve being repaired and/or the sutureordering/placement, the sutures are then secured to the annuloplastyprosthesis 200 as shown in FIG. 11. In particular, FIG. 11 illustratesthe annuloplasty prosthesis 200 secured to the tool 20, with the jaws32, 34 in the closed state. In the illustration of FIG. 11, the suturesare generally represented at 300, and consist of a series of suturepairs 302-318 as previously described. All of the sutures 300 arethreaded to the annuloplasty prosthesis 200 by, in one embodiment,entering at a bottom 320 of the annuloplasty prosthesis 200 and exitingthrough a top 322, with each of the sutures 300 being placed atapproximately a mid-line of the annuloplasty prosthesis 200. Whereprovided, the indicia 70 assists in directing the user to a properlocation of each of the sutures 300 relative a length of theannuloplasty prosthesis 200. For example, and with reference to themitral valve annulus 210 of FIG. 10A, the first suture pair 302(consisting of suture segments 302 a, 302 b) extends from the leftfibrous trigone 214 (FIG. 10A). The first segment 302 a is insertedapproximately 2 mm from a first end 324 of the annuloplasty prosthesis200. The indicia 70 preferably includes a marking indicative of this 2mm location. The second segment 302 b is similarly threaded through theannuloplasty prosthesis 200, at a desired spacing relative to the firstsegment 302 a (e.g., on the order of 4-5 mm). Once again, the indicia 70preferably includes markings indicative of length in 1 mm increments tofacilitate desired spacing between the suture segments 302 a, 302 brelative to the prosthesis 200. Adjacent suture pairs 304-318 aresimilarly placed through the annuloplasty prosthesis 200 at desiredspacings (e.g., adjacent suture pairs are approximately 1-2 mm apartfrom a previous suture pair).

After placing the individual suture pairs 302-318 through theannuloplasty prosthesis 200, the suture pairs 302-318 can beconsecutively organized and secured to the suture management device 28.For example, in one embodiment, after being inserted through theprosthesis 200, each suture segment is inserted within one of the slots178 a, 178 b by threading or pressing the suture segment between theedge 176 a or 176 b (FIG. 7A) of the flexible member 170 and thecorresponding leg 172 a or 172 b (FIG. 7A). The flexible member 170serves to frictionally retain the sutures within the slot 178 a or 178b. Unlike previous techniques, the suture management device 28 isprovided as part of the tool 20 in accordance with one embodiment, suchthat one or more additional, separate components are not required tomaintain the sutures 300 in an organized fashion, thereby greatlyreducing the time required to perform the procedure. In alternativeembodiments, however, separate devices apart from the tool 20 can beemployed to maintain the sutures 300.

With reference to FIG. 12, once all of the sutures 300 have been securedto the annuloplasty prosthesis 200, the suture needles are removed. Theannuloplasty prosthesis 200 can then be removed from the tool 20. Priorto removal, and in accordance with one embodiment, an effective endlength of the annuloplasty prosthesis 200 is noted. In particular, andas shown in FIG. 12, a last suture pair 332 has been placed at arelatively significant distance D from a second end 334 of theannuloplasty prosthesis 200. By way of background, and in oneembodiment, the annuloplasty prosthesis 200 is initially formed to havean overall length greater than the expected length necessary toaccommodate the heart valve annulus being repaired. In other words, theannuloplasty prosthesis 200 is not selected from an inventory ofdifferently-sized devices, but instead is more universally applicable tovirtually any sized heart valve annulus. With this in mind, once thelast suture pair 332 has been secured to the annuloplasty prosthesis200, the user will know the final length needed for proper implantation.Thus, in one embodiment, the user records an expected implantationlength of the annuloplasty prosthesis 200 by measuring approximately 2mm past the last suture pair 332. Once again, the indicia 70 facilitatean expedited determination of this implantation length via the graduatedmarkings.

With the implantation length of the annuloplasty prosthesis 200 noted,the suture 300 are removed as a bundle from the suture management device28. The annuloplasty prosthesis 200 can then be removed from the tool 20by transitioning the jaws 32, 34 from the closed state of FIG. 12 to anopen state of FIG. 13. Once again, transitioning of the jaws 32, 34 toan open state is accomplished by the user (not shown) applying a pushingor sliding force onto the actuator button 150 via the user's thumb orfinger. In the open state of FIG. 13, the annuloplasty prosthesis 200 isremoved from the channel 108, otherwise provided by the tool 20. Onceagain, removal of the annuloplasty prosthesis 200 from the tool 20 ischaracterized by the absence of a need to cut any portion of the tool 20or otherwise use a sharp instrument.

Once the annuloplasty prosthesis 200 has been removed from the tool 20,the tool 20 can be removed from the surgical site. The annuloplastyprosthesis 200 is then cut to define the desired, effective end length.For example, as shown in FIG. 13, a cutting implement 340 can beemployed to cut the annuloplasty prosthesis 200 at a point approximately2 mm from the last suture pair 332. The removed portion of theannuloplasty prosthesis 200 can then be disposed.

With reference to FIG. 14, the user (not shown) then pushes theappropriately-sized annuloplasty prosthesis 200 along the sutures 300(e.g., downwardly as shown by an arrow in FIG. 14) onto the valveannulus 210.

Finally, as shown in FIG. 15, each of the suture pairs 300 are tied viaknots 350 to securely hold the annuloplasty prosthesis 200 against thevalve annulus 210, and excess suture material is trimmed.

Thus, embodiments of the “Tool and Method for Implanting an AnnuloplastyProsthesis” are disclosed. One skilled in the art will appreciate thatthe present invention can be practiced with embodiments other than thosedisclosed. The disclosed embodiments are presented for purposes ofillustration and not limitation, and the present invention is limitedonly by the claims that follow.

1. A tool for use in implanting an annuloplasty prosthesis to repair aheart valve, the tool comprising: an elongate proximal portion forming ahandle; a distal portion including first and second jaws, at least oneof the first and second jaws being mounted for relative movement betweeni) an open state in which an end section of the first jaw is spacedapart from a corresponding end section of the second jaw, and ii) aclosed state in which a spacing between the corresponding end sectionsis less than the spacing in the open state; and an actuator mechanismincluding: a first post connected to the first jaw, a second postconnected to the second jaw, a spring disposed between the first andsecond posts to naturally force the jaw to the closed state, a slidablebutton connected to the spring and exteriorly accessible for receiving aforce from the user to overcome a bias of the spring and effectuatetransition of the jaws from the closed state to the open state.
 2. Thetool of claim 1, wherein at least one of the jaws forms a channel forreceiving an annuloplasty device, the channel defined by opposing, firstand second longitudinal faces and a lateral face, the channel having alength in a direction substantially perpendicular to a longitudinal axisof the handle, a height between the longitudinal faces, and a depth, thelength being greater than the height and the depth.
 3. The tool of claim1, wherein the actuator mechanism is configured such that the button ispushed to effectuate transition of the jaws from the closed state to theopen state.
 4. The tool of claim 1, wherein the button is connected tothe second post and is slidable relative to the first jaw, and furtherwherein the first and second jaws are pivotally connected at a pointspaced from the corresponding end sections such that when sufficientforce is applied to the button to overcome a bias of the spring, thesecond jaw pivots relative to the first jaw at the pivot point, causingthe jaws to transition from the closed state to the open state.
 5. Thetool of claim 1, wherein the button is positioned to slide in adirection substantially parallel with a longitudinal axis of the handle.6. The tool of claim 5, wherein the button is positioned such that whenthe handle is grasped in a palm of a user's hand, a thumb of the user'shand is capable of contacting the button.
 7. The tool of claim 1,wherein the tool is configured such that the button is slidable in adirection substantially perpendicular to a direction of movement of thecorresponding end sections as the jaws transition from the closed stateto the open state.
 8. The tool of claim 1, wherein at least one of thejaws defines a receiving surface for receiving an annuloplasty device,the receiving surface extending in a plane substantially perpendicularto a longitudinal axis of the handle.
 9. The tool of claim 8, whereinthe receiving surface is intermittent.
 10. The tool of claim 8, whereinthe receiving surface is provided as part of a channel.
 11. The tool ofclaim 8, wherein the receiving surface is linear.
 12. The tool of claim1, further comprising: at least one prosthesis holding member projectingfrom the end section of the first jaw.
 13. The tool of claim 12, whereinthe prosthesis holding member is a penetrating member configured topenetrate into a prosthesis otherwise positioned against the end sectionof the second jaw to resist separation between the prosthesis and thetool when the jaws are in the closed state.
 14. The tool of claim 1,further comprising: a suture management device associated with theelongate proximal portion for selectively receiving a portion of asuture.
 15. The tool of claim 14, wherein the suture management deviceincludes: a gap defined by opposing first and second legs at a proximalend of the handle; and a flexible, resilient member disposed within thegap; wherein a first slot is defined between an edge of the flexiblemember and the first leg.
 16. The tool of claim 15, wherein the flexiblemember is sized to encompass an entire width of the gap and ischaracterized by sufficient flexibility to allow releasable insertion ofa plurality of sutures within the first slot between the flexible memberand the first leg.
 17. The tool of claim 15, wherein a second slot isdefined between an opposing edge of the flexible member and the secondleg.
 18. The tool of claim 1, wherein the handle terminates at aproximal end spatially opposite the distal portion, the elongateproximal portion further including a neck extending from the handle tothe first jaw, and further wherein the button is slidably disposed overan exterior surface of the first jaw.
 19. A tool for use in implantingan annuloplasty prosthesis to repair a heart valve, the tool comprising:an elongate proximal portion forming a handle; and a distal portionincluding first and second jaws, at least one of the first and secondjaws being mounted for relative movement between i) an open state inwhich an end section of the first jaw is spaced apart from acorresponding end section of the second jaw, and ii) a closed state inwhich a spacing between the corresponding end sections is less than thespacing in the open state; wherein the second jaw defines an innersurface facing the first jaw and the end section of the second jawincludes a single row of fingers, the fingers being transversely spacedfrom one another relative to a longitudinal axis of the handle, each ofthe fingers including: a base projecting from the inner surface towardthe first jaw, a head projecting from the base, the head being spacedfrom the inner surface of the second jaw and extending from the base ina direction opposite the handle, wherein all of the fingers of the endsection of the second jaw are aligned with one another to form thesingle row of fingers; and further wherein the end section of the firstjaw includes a plurality of holding members projecting toward the secondjaw and between corresponding adjacent ones of the fingers in the closedstate, the holding members being transversely spaced from one anotherrelative to the longitudinal axis of the handle.
 20. The tool of claim19, wherein the end section of the second jaw further includes aplurality of projections spaced from, and extending substantiallyparallel to, the heads, the projections being transversely spaced fromone another relative to the longitudinal axis of the handle.
 21. Thetool of claim 20, wherein respective ones of the projections are alignedwith respective ones of the holding members.